ENDOTAK RELIANCE SG Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1993
Total Reports
3,379
Reports (30d)
34
Active Signals
1
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
High Shock Impedance Measurement
measurements, shock, remains service, shock impedance, ohms
33
reports
High Shock Impedance Leading to Revision
high range, shock, effects, additional adverse, impedance measurements
7
reports
Right Ventricular Lead Revision for Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
7
reports
Gradual Rise in Shock Impedance
reprogramming, shock, options, technical services, shock impedance
6
reports
CRT-D High Shock Impedance Measurement
defibrillator crt, resynchronization, crt, resynchronization therapy, therapy defibrillator
5
reports
Right Ventricular Lead Revision Due to Infection
explanted right, infection, infection additional, revision infection, lead revision
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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